Annuloplasty Device Having a Helical Anchor and Methods for its Use

• US 20070244554A1
• Filed: 04/12/2007
• Published: 10/18/2007
• Est. Priority Date: 04/12/2006
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Douk, Nareak, Rafiee, Nasser, Finney, Michael, Mas, Juan-Pablo, House, Morgan, Mac Donald, Stuart, Barone, David, Bloom, Eliot, Huynh, Rany
• Application Number:
  US11/734,547
• Publication Number:
  US 20070244554A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A system for modifying a heart valve annulus includes a helically helical anchored annuloplasty device delivered to the annulus via an elongated delivery member. The helical anchors of the devices disclosed herein are rotated into the valve annulus along an anchor guide by using a driver that is movably disposed in the delivery member. A tether is disposed within an inner channel of the helical anchor and a locking device is used to secure the annuloplasty device after the valve annulus has been modified. The annuloplasty device can be delivered to the annulus using, traditional surgical approach or a minimally invasive or catheter based methods.

Claims

1. A method for treating regurgitation in a mitral valve by modifying the shape of the mitral valve annulus, comprising:

selecting at least one annuloplasty device delivery member;

selecting an annuloplasty device comprising at least one helical anchor and an elongated flexible tether, the helical anchor having a long axis, a distal end with a sharpened tip portion, a proximal end, and a plurality of coils defining an inner channel that communicates along the length of the helical anchor and the tether having a first end and a second end;

implanting the annuloplasty device by rotating the at least one helical anchor into the valve annulus such that the long axis of the helical anchor extends along the valve annulus and the tether is routed through the inner channel such that one end of the tether extends from the distal end of the helical anchor and the other end of the tether extends from the proximal end of the helical anchor;

manipulating the tether to modify the shape of the valve annulus such that the regurgitation is reduced;

securing the tether to maintain the modified shape of the valve annulus; and

whereby the mitral valve has a posterior commisure and an anterior commisure, and the valve annulus has a posterior portion, and anterior portion, and two trigones.

2. The method of claim 1 comprising the additional steps of:

selecting an additional annuloplasty device delivery member;

selecting an additional helical anchor, the helical anchor having a long axis, a distal end with a sharpened tip portion, a proximal end, and a plurality of coils defining an inner channel that communicates along the length of the helical anchor;

implanting the helical anchor by rotating the helical anchor into the valve annulus such that the long axis of the helical anchor extends along the valve annulus and the tether is routed through the inner channel such that one end of the tether extends from the distal end of the helical anchor and the other end of the tether extends from the proximal end of the helical anchor;

repeating the steps of selecting a delivery member, selecting a helical anchor, and implanting the helical anchor until a predetermined number of helical anchors has been implanted; and

wherein the additional steps are completed before the step of manipulating the tether to modify the shape of the valve annulus such that the regurgitation is reduced.

3. The method of claim 2 wherein the number of helical anchors implanted is in the range of two to eight.

4. The method of claim 2 wherein multiple helical anchors are implanted on the posterior portion of the valve annulus.

5. The method of claim 4 wherein the number of helical anchors implanted on the posterior portion of the valve annulus is in the range of two to six.

6. The method of claim 4 wherein three helical anchors are implanted on the posterior portion of the valve annulus.

7. The method of claim 2 wherein multiple helical anchors are implanted on the anterior portion of the valve annulus.

8. The method of claim 7 wherein two helical anchors are implanted on the anterior portion of the valve annulus.

9. The method of claim 2 wherein multiple helical anchors are implanted on the posterior portion of the valve annulus and multiple helical anchors are implanted on the anterior portion of the valve annulus.

10. The method of claim 2 wherein a single helical anchor is implanted on the posterior portion of the valve annulus and multiple helical anchors are implanted on the anterior portion of the valve annulus.

11. The method of claim 2 wherein multiple helical anchors are implanted on the posterior portion of the valve annulus and a single helical anchor is implanted on the anterior portion of the valve annulus.

12. The method of claim 2 wherein a single helical anchor is implanted on the posterior portion of the valve annulus and a single helical anchor is implanted on the anterior portion of the valve annulus.

13. The method of claim 2 wherein multiple helical anchors are implanted along the posterior portion of the valve annulus from a portion of the valve annulus adjacent to the posterior commisure to a portion of the valve annulus adjacent to the anterior commisure.

14. The method of claim 2 wherein multiple helical anchors are implanted along the posterior portion of the valve annulus between the trigones.

15. The method of claim 2 wherein a single helical anchor is implanted along the posterior portion of the valve annulus from a portion of the valve annulus adjacent to the posterior commisure to a portion of the valve annulus adjacent to the anterior commisure.

16. The method of claim 2 wherein a single helical anchor is implanted along the posterior potion of the valve annulus between the trigones.

17. The method of claim 2 wherein the steps of manipulating the tether and securing the tether comprise creating a loop in the tether;

making the loop smaller such that the tether applies a force to the helical anchors until the shape of the valve annulus had been modified to a desired level such that regurgitation is reduced;

using a locking device to secure the tether and maintain the desired level of modification; and

cutting any excess tether material from the tether such that the locking device now joins secures the first end of the tether to the second end of the tether.

18. The method of claim 17 wherein the locking device is selected from the group consisting of a surgeons knot and a snell knot.

19. The method of claim 17 wherein the locking device is a tether stop having a size and shape such that it cannot pass into the inner channel of the helical anchors, the tether stop further having at least one tether channel communicating therethrough.

21. The method of claim 17 wherein after the shape of the valve annulus has been altered, the locking device is located along the valve annulus adjacent to the posterior commisure.

22. The method of claim 17 wherein after the shape of the valve annulus has been altered, the locking device is located along the valve annulus adjacent to the anterior commisure.

23. The method of claim 17 wherein after the shape of the valve annulus has been altered, the locking device is located adjacent to a portion of the valve annulus on the posterior side of the mitral valve.

24. The method of claim 17 wherein after the shape of the valve annulus has been altered, the locking device is located adjacent to a portion of the valve annulus on the anterior side of the mitral valve.

20. The method of claim 20 wherein the tether has a plurality of locking devices spaced along at least a portion thereof, and the locking devices have a shape that allows them to pass through the tether stop when moving in a first direction, but does not allow them to pass through the tether stop when moving in a second direction.

25. A method for treating regurgitation in a mitral valve by modifying the shape of the mitral valve annulus, comprising:

selecting at least one annuloplasty device delivery member;

selecting an annuloplasty device comprising a plurality of helical anchors and an elongated flexible tether, the helical anchors each having a long axis, a distal end with a sharpened tip portion, a proximal end, and a plurality of coils defining an inner channel that communicates along the length of the helical anchor and the tether having a first end and a second end;

implanting the annuloplasty device by rotating each helical anchor into the valve annulus such that the long axis of the helical anchor extends along the valve annulus and the tether is routed through the inner channel such that one end of the tether extends from the distal end of the helical anchor and the other end of the tether extends from the proximal end of the helical anchor;

manipulating the tether to create a loop;

making the loop smaller such that the tether applies a force to the helical anchors until the shape of the valve annulus had been modified to a desired level such that regurgitation is reduced;

using a locking device to secure the tether and maintain the desired level of modification;

cutting any excess tether material from the tether such that the locking device now joins secures the first end of the tether to the second end of the tether; and

whereby the mitral valve has a posterior commisure and an anterior commisure, and the valve annulus has a posterior portion, and anterior portion, and two trigones.

26. The method of claim 25 wherein multiple helical anchors are implanted on the posterior portion of the valve annulus.

27. The method of claim 25 wherein multiple helical anchors are implanted on the anterior portion of the valve annulus.

28. The method of claim 25 wherein a single helical anchor is implanted on the posterior portion of the valve annulus.

29. The method of claim 25 wherein a single helical anchor is implanted on the anterior portion of the valve annulus.

30. The method of claim 25 wherein the portion of the annuloplasty device implanted along the posterior portion of the valve annulus is located along the valve annulus from a portion of the valve annulus adjacent to the posterior commisure to a portion of the valve annulus adjacent to the anterior commisure.

31. The method of claim 25 wherein the portion of the annuloplasty device implanted along the posterior portion of the valve annulus is located along the valve annulus between the trigones.

32. The method of claim 25 wherein after the shape of the valve has been altered, the locking device is located along the valve annulus adjacent to the posterior commisure.

33. The method of claim 25 wherein after the shape of the valve has been altered, the locking device is located along the valve annulus adjacent to the anterior commisure.

34. The method of claim 25 wherein after the shape of the valve has been altered, the locking device is located adjacent to a portion of the valve annulus on the posterior side of the mitral valve.

35. The method of claim 25 wherein after the shape of the valve has been altered, the locking device is located adjacent to a portion of the valve annulus on the anterior side of the mitral valve.

36. The method of claim 25 wherein implanting the helical anchors into the valve annulus comprises rotating and translating a helical anchor through the valve annulus in response to rotation and translation of a drive member operably connected to the helical anchor.

37. A method for treating regurgitation in a mitral valve by modifying the shape of the mitral valve annulus, comprising:

selecting at least one annuloplasty device delivery member;

selecting an annuloplasty device comprising a single helical anchor and an elongated flexible tether, the helical anchor having a long axis, a distal end with a sharpened tip portion, a proximal end, and a plurality of coils defining an inner channel that communicates along the length of the helical anchor and the tether having a first end and a second end;

implanting the annuloplasty device by rotating the helical anchor into the valve annulus such that the long axis of the helical anchor extends along the valve annulus and the tether is routed through the inner channel such that one end of the tether extends from the distal end of the helical anchor and the other end of the tether extends from the proximal end of the helical anchor;

manipulating the tether to shorten the length of the long axis of the helical anchor;

shortening the length of the long axis of the helical anchor until the shape of the valve annulus had been modified to a desired level such that regurgitation is reduced;

using a locking device to secure the tether and maintain the desired level of modification;

cutting any excess tether material from the tether such that the locking device now joins secures the first end of the tether to the second end of the tether; and

whereby the mitral valve has a posterior commisure and an anterior commisure, and the valve annulus has a posterior portion, and anterior portion, and two trigones.

38. The method of claim 37 wherein implanting the annuloplasty device into a portion of the valve annulus comprises rotating and translating the helical anchor through the portion of the valve annulus in response to rotation and translation of a drive member operably connected to the helical anchor.

39. The method of claim 37 wherein the helical anchor is implanted along the posterior portion of the valve annulus from a portion of the valve annulus adjacent to the posterior commisure to a portion of the valve annulus adjacent to the anterior commisure.

40. The method of claim 37 wherein the helical anchor is implanted along the posterior portion of the valve annulus between the trigones.

41. The method of claim 37 wherein the step of shortening the length of the long axis of the helical anchor is accomplished by forming the tether into a loop and making the loop smaller until the helical anchor is shortened to a desired length.

42. The method of claim 37 wherein the step of shortening the length of the long axis of the helical anchor comprises securing the first end of the tether at the distal end of the helical anchor and applying tension to the tether by pulling on the portion of tether that extends from the proximal end of the helical anchor until the helical anchor is shortened to a desired length and securing the tether at the proximal end of the helical anchor to maintain the helical anchor at the desired length.

43. The method of claim 42 wherein the first end of the tether is tied to the distal end of the anchor, the helical anchor is shortened, and the tether is then tied to the proximal end of the helical anchor.

44. The method of claim 42 wherein the first end of the tether is secured to a first tether stop having a size and shape such that it cannot pass into the inner channel of the helical anchor, the helical anchor is shortened, and the tether is then secured to a second tether stop at the proximal end of the helical anchor.